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NCT00177164 · ClinicalTrials.gov registry record · Phase 3
Risperdal Consta for Bipolar Disorder
A Phase 3 study, sponsored by University of Pittsburgh.
- Completed
- Registry status
- Phase 3
- Development phase
- 50
- Enrollment target
NCT00177164: Completed Phase 3 study, sponsored by University of Pittsburgh.
NCT00177164 is a Phase 3 study that has completed, run by University of Pittsburgh. The registered enrollment target is 50 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00177164, a Phase 3 study, has completed, sponsored by University of Pittsburgh.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 50 participants
- Enrollment target
Study Summary
We recruited 50 consenting adult subjects with DSM-IV TR diagnoses of bipolar disorder who were about to initiate or switch their current antipsychotic agent. Only 48 patients (23 in the risperidone LAI group and 25 in the oral AAP group) contributed data to the assessments. Patients were titrated and cross-tapered during a 3 month titration and stabilization phase. They were followed for an additional 12 months. Clinical outcomes such as study drop out, adverse events, worsening of symptoms, crisis interventions, need for additional medication, hospitalizations etc. were evaluated from months 3 to 15. The numbers of clinical events (pooled) will be used to evaluate if the long acting injectable form of risperidone has an advantage over the oral second generation antipsychotic agents in terms of treatment continuity and clinical stability.
Interventions
- DRUG Injectable Risperidone (Consta) or oral antipsychotic
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2003-11 |
| Est. Completion | 2009-12 |
| Phase | Phase 3 |
What the finished NCT00177164 record still lists
NCT00177164 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 1 intervention - of which Injectable Risperidone (Consta) or oral antipsychotic is the first listed.
NCT00177164 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00177164 about?
NCT00177164 is a clinical study titled "Risperdal Consta for Bipolar Disorder". We recruited 50 consenting adult subjects with DSM-IV TR diagnoses of bipolar disorder who were about to initiate or switch their current antipsychotic agent. Only 48 patients (23 in the risperidone LAI group and 25 in the oral AAP group) contributed data to the assessments. Patients were titrated a...
What is the current status of trial NCT00177164?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 50 participants. The study started on 2003-11. Estimated completion is 2009-12.
What interventions are being tested in trial NCT00177164?
The interventions under investigation include: Injectable Risperidone (Consta) or oral antipsychotic (DRUG).
Who is sponsoring clinical trial NCT00177164?
This trial is sponsored by University of Pittsburgh, which has 1,238 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00177164's enrollment target sits among peer trials
50 1844th of 2000 higher than 141 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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